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Research Compliance in The University of Texas System Charles G' Chaffin Systemwide Compliance Offic

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History of Research Compliance prior to 1998 ... Tropical Storm Allison. Floods Houston Medical School. 10. Risks. IT Security ... – PowerPoint PPT presentation

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Title: Research Compliance in The University of Texas System Charles G' Chaffin Systemwide Compliance Offic


1
Research Compliance in The University of Texas
SystemCharles G. ChaffinSystem-wide Compliance
OfficerThe University of Texas System
  • HCCA
  • Research Compliance Conference
  • November 1, 2007

2
AGENDA
  • History of Research Compliance prior to 1998
  • Impact of Institutional Compliance Program on
    Research Compliance
  • Common Infrastructure
  • Collaboration
  • Pro-active monitoring of the external research
    compliance environment
  • Challenges Encountered
  • Secrets of Success
  • Benefits to Research from UT System Compliance
    Approach

3
Research Compliance in the University of Texas
System Prior to 1998
  • Weak organizational structures with no Vice
    Chancellor and few Vice Presidents for Research
  • Little sharing or coordination between
    institutions
  • Limited internal monitoring, except for
    appropriate expenditures
  • Limited auditing, except federal A-133

4
Research Compliance in the University of Texas
System Prior to 1998
  • UTMB Human Subject Research suspended for one
    month
  • Complaint regarding use of prisoners in research

5
Common Infrastructure
  • Required Components
  • Standard Risk Management Model
  • Common Risk Areas
  • Acceptable Assurance Activities

6
Required Components to Manage Research Risks
  • Single Responsible Party for Research Compliance
  • Risk Assessment Methodology
  • Continuous Monitoring Plan
  • Training Plan
  • Reporting Plan

7
Responsible Party
  • Financial Reporting
  • Including Time Effort
  • Human Subjects
  • Including IRB
  • Animals
  • Including IACUC
  • Environmental Health Safety
  • Including Select Agents

8
Standard Risk Management Model
  • Use facilitated workshops with brainstorming to
    gather information
  • Determine major activity areas performed to
    achieve goals and objectives
  • Identify the risks associated with each major
    activity area
  • Prioritize risks based on (1) impact on
    achievement of goals and objectives and (2)
    likelihood of occurrence using subjective values
  • Optimize the portfolio of controls chosen to
    manage the prioritized risks
  • Develop a plan to continuously monitor the
    application of the optimized controls

9
Risks
  • Tropical Storm Allison
  • Floods Houston Medical School

10
Risks
  • IT Security
  • Release of 200,000 Social Security Numbers

11
Common Risk Areas
  • Time Effort Reporting
  • Allowable Costs (including indirect cost
    recovery)
  • Animal Research
  • Human Subjects Research (IRB)
  • Institutional Oversight (Office of Sponsored
    Research)
  • Conflict of Interest Integrity
  • Technology Licensing (including Export Control)
  • Environmental Health Safety (Labs)
  • Biosafety National Security
  • Medical Billing on Research Grants
  • Information Technology Security

12
Acceptable Quality Assurance Activities
  • Supervisory Review (Operating Management)
  • Continuous Monitoring (Institutional Oversight)
  • Internal line management monitoring
  • Compliance Office monitoring
  • External vendor monitoring
  • Peer Reviews
  • Accreditation teams
  • External experts in area to be reviewed
  • Audits
  • Internal Audit
  • OIG or other External Auditors

13
Quality Assurance Examples
  • Time Effort
  • Discussions with PI
  • Human Research
  • Protocol Inspections
  • IT Security
  • Encryption and Scans

14
Collaboration
  • High Risk Area Working Groups
  • University Compliance Group
  • Conferences Materials

15
High Risk Working Groups
  • Basic Research
  • Clinical Research
  • Time Effort Reporting
  • Medical Billing
  • Conflict of Interest

16
University Compliance Group
  • Formed after 2nd Annual Conference on Effective
    Compliance Systems in Higher Education in 2002
  • Research Universities
  • Electronic Mailing List Teleconferences

17
Conferences Materials
  • Five National Conferences on Effective Compliance
    Systems in Higher Education
  • Book Effective Compliance Systems A Practical
    Guide for Educational Institutions, Institute of
    Internal Auditors, 2001
  • Websites
  • UT System-wide Compliance
  • Individual Institutions UT Austin Research
  • Presentations
  • HCCA, NCURA, IIA, ACUA, NACUBO, COGR
  • Regional Local Organizations

18
Pro-active Monitoring of External Compliance
Environment
  • Higher Education Community
  • Daily news
  • Trade Organization National Conferences
  • Higher Education Trade Organizations (HCCA,
    NCURA, ACUA, NACUBO)
  • Federal Government OIG Activities
  • Annual Audit Plans
  • Hot Issues
  • Actions with other higher education and hospital
    entities

19
Challenges Encountered
  • No System Vice Chancellor for Research
  • Institutional Vice President for Research has no
    dedicated research compliance resources or
    compliance authority
  • No single responsible individual for research
    compliance
  • Research compliance activities distributed
    throughout the organizational structure of the
    institution

20
Secrets of Success
  • Simple, systematic repeatable methodology for
    assessing and managing risks
  • Utilize the collective knowledge of your
    colleagues
  • Monitor the research compliance environment
    because it changes constantly
  • Recognize that the change may not be in the
    what but in the what is important today

21
Secrets of Success
  • System-wide Working Groups
  • Time Effort
  • IRB
  • IACUC
  • EHS
  • Accountability to Institutional Compliance
  • Quarterly Reports
  • Inspections Audits

22
Benefits to Research from The UT System
Institutional Compliance Program
  • Represented a cultural shift from directives
    edicts to risk management by the right
    individuals
  • Identified a risk management model in which
    assignment of responsibilities became obvious
  • Delineated a universal process that could be
    adapted and applied in research administrative
    units, research centers, colleges, academic
    departments, research groups, and principal
    investigators
  • Provided cross-training for key research
    administrators
  • Provided road map for training future
    administrators
  • Identified several oversights in research
    compliance
  • Source U.T. Basic Research High Risk Advisory
    Committee Final Report, pg. 8

23
The University of Texas System-wide Compliance
Program Websites
  • System-wide Compliance Program
  • www.utsystem.edu/compliance
  • 5th Conference for Effective Compliance Systems
    in Higher Education
  • www.utsystem.edu/compliance/conference2007.htm
  • Basic Research High Risk Working Group
  • www.utexas.edu/administration/oic/research

24
Thank you
  • cchaffin_at_utsystem.edu
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